The present invention relates to a compression suture device.
The device is particularly but not exclusively suitable for the surgical treatment of hemorrhoids.
Various techniques for the surgical treatment of hemorrhoids are available.
The two currently most widely known and used methods are the open technique (used mainly in Europe) and the closed technique (used mainly in the American continent).
The closed technique has considerable advantages in terms of painful complications and speed of healing with respect to the open technique, although it requires greater training of the surgeon and is more expensive.
These techniques have always been performed with reusable surgical instruments and the stitches have been applied with the classic needle-and-thread method.
During the second half of this century, various surgical instruments known as surgical staplers have been provided in order to facilitate the execution of linear or circular sutures, making them faster and safer even in areas and conditions in which the classical manual suture entails difficulties.
These instruments can be of the throwaway type or not, perform linear or circumferential sutures, and act by applying a plurality of staples which are very similar to the typical metallic staples of an ordinary office stapler.
Since these staples are usually permanent, titanium has been used preferentially as a material, in view of the known characteristics of biocompatibility, strength, light weight, and elasticity of this material.
There are also other suture systems, which however utilize the capacity of biological tissues to heal when they are kept joined with a certain pressure and for a certain period of time.
This last type of suture is commonly known as compression suture.
Compression sutures are used for the synthesis of hollow viscera after the surgical removal of a segment and for surface tissues (skin and mucous membranes) and are performed by means of bandages or adhesive bands, elastic rings made of latex or silicone.
The considerable advantage of compression suture systems is that once their task has been completed they can be removed or they can fall spontaneously and be subsequently eliminated from the body.
Substantially, these are xe2x80x9ccontinuousxe2x80x9d systems, such as an elastic element, a synthetic thread or a body, with a possibly nonstandard geometric shape, and they cannot be applied in the case of a long and longitudinal suture, especially if it is enclosed in a small cavity.
As regards hemorrhoids, circular staplers designed and manufactured specifically for this purpose have recently been used.
This technique allows to rapidly perform the suture inside the anal canal, above the dentate line and therefore in a region where pain sensitivity is very limited.
Actually, this is not a true hemorrhoidectomy but rather a correction of the hemorrhoidal prolapse which is often associated with hemorrhoids.
Adequate and complete treatment of hemorrhoids must entail a xe2x80x9cradical hemorrhoidectomyxe2x80x9d, i.e., the complete removal of the hemorrhoidal columns in order to prevent relapses which can occur starting from the abnormal swelling of the residual hemorrhoidal tissue.
Moreover, complete treatment of hemorrhoids entails removal of the external hemorrhoidal bundles, in order to prevent any future disorder linked to alteration of these structures.
The known techniques for the treatment and healing of hemorrhoids are not free from drawbacks.
Hemorrhoidectomy with a circular stapler xe2x80x9csuspendsxe2x80x9d the hemorrhoidal tissue in the anal canal but does not remove it completely: approximately the lower half of the internal hemorrhoids and all of the external hemorrhoids are in fact left in place.
There is a certain incidence of external hemorrhoidal thromboses and thrombophlebitides in the immediate postoperative period which eliminates the potential benefits of the use of the stapler.
Various degrees of postoperative anal stenosis have been observed after the use of a circular stapler for hemorrhoids.
It is necessary to wait longer to reveal any relapses arising from the residual internal hemorrhoids.
Although made of an inert material (titanium), the staples used for the suture cannot be eliminated, and this entails, for the patients, psychological unease in accepting foreign material permanently in their body as well as physical discomfort, such as small losses of blood when the friction of bulky stools causes the separation of a few staples even long after the operation.
Moreover, a single element compressing the hemorrhoidal tissue along its entire length would produce an excessively rigid suture, since the columns to be removed for radical hemorrhoidectomy are generally three, one in the left quadrant and two in the right quadrant, front and rear, the combination of three rigid elements would cause excessive overall rigidity in the anal canal and might compromise defecation.
Finally, the cost of the procedure is particularly high and linked to the cost of the throwaway stapler that is used.
The aim of the present invention is to provide compression suture devices which allow to provide an effective hemorrhoidectomy with the closed technique.
A consequent object is to join the tissue without permanent stitches.
Another object is to achieve return of the tissue to total elasticity.
Another object is to avoid patient blood losses or in any case drastically reduce their extent.
Another object is complete and radical removal of the hemorrhoidal columns.
Another object is to eliminate the problem of hemorrhoids, with the possibility to correct any concurrent occult mucous membrane rectal prolapse.
Another object is to provide compression suture devices which are adapted to be used in straight, curved and circular shapes on organic tissues that have already been moved mutually close by other instruments and are to be kept joined and compressed together in order to be sutured and/or connected permanently.
Another object is to provide compression suture devices which are eliminated spontaneously and without the need for human and/or mechanical intervention.
Another object is to provide compression suture devices which are applied by means of applicators having different apertures, thicknesses, dimensions and shapes so as to be used in any situation or physiological region, hemorrhoids not being a requirement.
Another object is to provide compression suture devices which can be arranged on a same plane and/or on different planes, whether parallel or staggered or consecutive.
Another object is to provide compression suture devices which can also coexist with devices having different shapes, materials and dimensions, on the same line and on different planes.
Another object is to provide a compression suture which can also include or not (simultaneously, before or after application) the possibility to perform incision, cutting, elimination, cauterization and/or coagulation of the organic tissue, optionally obtained by means of high-frequency applications or the like, in combination with each other or not, and which allows this possibility to be included and/or provided by the applicator itself or not.
Another object is to provide a suture which can also be applied to other surgical procedures which entail the need to join and compress organic tissues and to allow subsequent elimination of the suture devices through natural and/or physiological pathways.
Another object of the invention is to maintain all the advantages of the closed technique in hemorrhoid treatment, making it easier and faster to perform and within the grasp of any surgeon even if he is not expert in the field of proctology.
Another object is to maintain relatively low costs.
This aim and these and other objects which will become better apparent hereinafter are achieved by a compression suture device, comprising two mutually opposite sections which cooperate with mutual connection means and a clamping portion for at least two flaps of organic tissue placed in mutual contact.